New Journal of Commercial Biotechnology issue

Journal of Commercial Biotechnology Vol 19, Issue 2 (2013)

Capturing Value
G. Steven Burrill
Today’s pressure on pharmaceutical companies reflects greater pressures throughout the entire healthcare ecosystem as payers, patients, and providers wrestle with escalating costs and drive  healthcare systems around the world away from being cost-based to becoming value-based.  For pharmaceutical companies, this means not only a greater emphasis on creating value, but seeking new ways to capture value as well, particularly at a time when drugs will need to demonstrate they provide benefits commensurate with their costs and governments and payers squeeze down prices…
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Defining valuable information in a shifting industry
Andrew F Bourgoin
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Commercial Biotechnology in Mexico
Minerva Valdes, Fernando Quezada
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Technology Transfer: Bridging academic research and society – a communicative approach
Martin Vad Bennetzen, Lars Stig Møller
To make basic research transcend the walls of a university for the benefit of the society, technology transfer processes such as patenting, market analysis, and economic assessment are essential. Therefore small dedicated units, called technology transfer offices, have emerged during the last four decades…
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The funding ecosystem of early-stage biotechnology firms and its misalignment with interests of firms, of the biotechnology industry and with global disease burden
Gergely Toth
The development and commercialization of new therapeutics have had immense impact on the quality and length of human life.  Nevertheless, the biotechnology and the pharmaceutical industry have evolved to be driven mostly by a profit oriented market system, in which distinct stakeholders interact with different motivations to make the development and commercialization of therapeutics a reality…
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A Patient Centric Commercial Model for Cancer Care
Sanjay Rao
Cancer is one of the most challenging diseases of all – not only in terms of the clinical barriers to offering its sufferers respite from devastating consequences, but also to manufacturers and marketers of treatments that attempt to control its impact. Products developed and manufactured through biotechnology dominate the commercial landscape for treating a variety of cancer types…
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Developing Cell Therapies: Enabling cost prediction by value systems modeling to manage developmental risk.
Mark Joseph McCall, David John Williams
This work quantifies the highest risk activities and interdependencies in cell therapy new product development (NPD).  A simulation model based upon an activates based and information driven  approach of the Design Structure Matrix (DSM), using Latin Hypercube sampling methods with discrete event simulation evaluated the interdependencies between critical development tasks…
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Challenges and prospects for monoclonal antibodies in China
Honghao Shi, Meiwan Chen, Yunzhen Shi, Hao Hu, Yitao Wang
The technology of monoclonal antibodies has been developed since the 1990s and is attracting more and more attention in China during the 21st century. The first monoclonal antibody product was introduced by the Chinese local producer in 1999, and presently seven products are listed, of which three are humanized products…
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A Business Perspective on IP: Open Innovation vs. Open Source in Commercializing Biotechnology
Arthur A. Boni
Abstract – In this article, we address the issues that are involved when developing a strategy for commercializing a discovery that is novel, useful, and non-obvious to someone skilled in the art.  Patent(s) may be used as one means of providing a competitive advantage, and in addition this method is quite common as a means to monetize the intellectual asset…
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Getting Social with Biotechnology Business Development
Tim McCready
Social media is becoming increasingly important in business. While the lack of regulations makes marketing online to consumers a challenge in the life sciences, social media offers significant opportunities to the industry by complementing traditional business development and capital raising activities…
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Bowman v. Monsanto: Revisiting the Exhaustion Doctrine and its Application to Biotechnology and Digital Technologies
Susan Kling Finston
On February 19, 2013, the U.S. Supreme Court heard oral argument in Bowman v. Monsanto – the first case to directly present the question of how the Exhaustion Doctrine should apply to patents relating to biotechnology and digital technology inventions.  The Petitioner, Vernon Hugh Bowman, asserts that the Exhaustion Doctrine should be extended to advanced agricultural technologies where the technology itself is contained in genetically modified seeds that may be reproduced through successive generations of seeds without limitation, and that companies like Monsanto can instead rely on remedies found in contract law to protect its commercial interests…
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Should the HHS Decision to Overrule FDA on Plan B Be Reversed
Peter J. Pitts
On December 7, 2011, Secretary of Health and Human Services Kathleen Sebelius overruled a decision of the Food and Drug Administration (FDA) on the over-the-counter (OTC) status of emergency contraception. What will be the repercussions of Secretary Sebelius’s action? Why is the act itself of far greater long-term significance than the transitory regulatory action it impacts? By reversing an FDA decision, the Secretary has set a dangerous precedent for all-comers to lobby Congress, the Department of Health and Human Services (HHS) and the White House on any and all FDA decisions—directly inserting politics into what must be a scientifically driven process…
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Journal of Commercial Biotechnology October 2012 Issue Now Available

Journal of Commercial Biotechnology Vol 18, Issue 4 (2012)

The Birth of a Discipline
Arlen Meyers
Bioentrepreneurship is a new academic discipline Full details at theJournal of Commercial Biotechnology

Not fully harmonized: Differences in biotechnology patenting between Europe and the United States
Brian R Dorn, Zoë Birtle
There has been a trend of worldwide harmonization of patent laws. Due to the continuing harmonization, examination of patents in Europe and the United States are very similar.  However, examination standards between the two patent offices can differ. Thus, applicants should be aware of the differences between examination standards since both standards need to be addressed in the single patent application…
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CROs in Modern-day China
Steven S Ma
Contract research organization (CRO) outsourcing has become a critical strategy for multinational biopharmaceutical companies looking to reduce costs, time-to-market and expanding their pipelines as blockbuster patents expire. Much of the growth in the CRO industry is coming from emerging markets, such as China and India…
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Analyzing the Broadening Scope of Patentability in the Advancing Field of Biotechnology
Jessica Downing
The current U.S. patent system is considered to provide the broadest patent protection of all patent systems in existence, especially with respect to the biotechnology industry. Advances in science and technology have been key contributors to the growth and development of legislation controlling patent law…
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Biotechnology in Brazil: An Industry Overview
Ezequiel Zylberberg, Claudia Zylberberg, Asli Ceylan Oner
Recently becoming the sixth largest economy in the world, Brazil has relied, in large part, on its comparative advantages of resource extraction and agriculture. Sustained long-term growth will require Brazil moves into higher value industries that build of off its comparative advantage. Biotechnology has surfaced as a sector of strategic importance, and government involvement in finance, education and research and development has created an industry on the cusp of global significance…
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Lessons on Emerging Markets and Global Health
Victoria Y. Fan, Bryan A liang
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Global Health Diplomacy and Management Mechanisms of US-China Public Health Collaborations in China: Lessons for Emerging Markets
Matthew David Brown
China is the largest emerging market in the world…
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Emerging Markets and Differential Pricing Policies: A Question of Global Health?
James Class
Over the past decades, global health has moved from discrete disease campaigns to major developmental strategies. However, medication affordability remains an important, unsolved challenge for industry and the global community. This effort requires coordinated actions by multiple stakeholders. Industry can play a specific role through responsible, differentiated pricing of medicines…
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Tipping Point: Biosimilars, Emerging Markets, and Public-Private Engagement to Promote Global Health
Bryan A Liang
Biosimilars, also known as follow on biologics, are complex biotechnology drugs that are similar, but not identical, to original biologic drug forms, and represent potential lower cost versions that may improve access. Yet biologics and their biosimilar forms have a key safety concern: unwanted immunogenicity…
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Globalization, Evolution and Emergence of Direct-to-Consumer Advertising: Are Emerging Markets the Next Pharmaceutical Marketing Frontier?
Timothy Ken Mackey
Pharmaceutical marketing has rapidly evolved over the past century and has now entered the digital revolution.  This is exemplified by the rise of direct-to-consumer-advertising (“DTCA”), which has traditionally been only allowed in the United States and New Zealand in developed countries, but is now expanding in reach to other jurisdictions…
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The Partnership for Safe Medicines-India: Lessons for Emerging Markets
Bejon Kumar Misra
While medicines are always expected to be a safe remedy for human ailments, unfortunately, there is also the phenomenon of ‘unsafe medicines’ due to unscrupulous elements in society manufacturing and marketing fake, spurious, mislabeled medicines, as well as medicines with sub-standard ingredients…
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Blood Supply and Safety in the Developing World: Considerations for Emerging Markets
William Riley, Jeffrey McCullough
Assuring a safe and adequate blood supply in developing nations such as emerging markets is a daunting challenge that directly affects fundamental health metrics of a country. Numerous mortalities can be reduced when an effective national blood transfusion system is in place including leading causes of death such as maternal hemorrhage, sickle cell anemia, and malaria…
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Biomarketing strategy and tactics 101 PART III of III
Dimitris Dogramatzis
The American Marketing Association defines marketing as the activity, set of institutions, and processes for creating, communicating, delivering, and exchanging offerings that have value for customers, clients, partners, and society at large. According to the Pharmaceutical Research and Manufacturers of America appropriate marketing of medicines ensures that patients have access to the products they need and that the products are used correctly for maximum patient benefit…
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The University of California, Davis, collaborative model for biotechnology education and training
Judith Ann Kjelstrom
UC Davis and its partners are addressing the need for innovation and entrepreneurship in graduate education and training. This paper will showcase the Designated Emphasis in Biotechnology graduate education program, cross-disciplinary partnerships and technology brokering. These interactions can bring diverse groups of individuals together to translate ideas into real world applications…
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